BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON LX®I 725 SYSTEM

    MDR report key: 3781684 · Received April 30, 2014

    Report

    Report Number
    2050012-2014-00218
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Date of Event
    April 3, 2014
    Report Date
    April 4, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K023049
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER (BEC) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS THE INSTRUMENT. THE FSE OBSERVED INSUFFICIENT SAMPLE ASPIRATION ON THE CTA AND BUBBLING IN THE ALIQUOT VESSEL. THE FSE REPLACED THE SYRINGES AND THE ALIQUOT PROBE ON THE CTA. THE FSE PRIMED THE INSTRUMENT, PERFORMED ALIGNMENTS, AND RAN CUSTOMER QUALITY CONTROL (QC.) RESULTS WERE WITHIN CUSTOMER SPECIFICATIONS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FALSE LOW RESULTS FOR CREATINE KINASE-MB (CK-MB) AND B-TYPE NATRIURETIC PEPTIDE-2 (BNP2) ON SAMPLES RUN THROUGH THE CLOSED TUBE ALIQUOTER (CTA) OF THE ACCESS2 OF A SYNCHRON LXI 725 SYSTEM. FOUR PATIENT RESULTS WERE AFFECTED AND REPORTED OUT OF THE LABORATORY. THE PATIENT SAMPLES WERE RERUN ON THE SAME LXI ANALYZER AND ON A SECOND LXI ANALYZER. THE RESULTS WERE LATER AMENDED. THE CUSTOMER IS NOT AWARE OF ANY CHANGE TO PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259863 SYNCHRON LX®I 725 SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 94 YR